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Purpose

The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286. Another secondary objective is to evaluate the safety and tolerability of TEV-56286. The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.

Condition

Eligibility

Eligible Ages
Between 30 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • is considered to be "clinically possible" or "clinically probable" MSA as determined by the Gilman criteria - is medically and psychiatrically stable, as indicated by medical and psychiatric history, as well as physical and neurological examination - Females of child bearing potential (CBP) may be included only if they have a negative pregnancy test at the screening and baseline visits - Females of CBP whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods - Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of CBP must use, together with their female partners, highly effective birth control methods - Additional criteria apply; please contact the investigator for more information

Exclusion Criteria

  • has 2 or more relatives with history of MSA, suggestive of an alternative diagnosis other than MSA - has participated in another clinical study involving administration of an IMP within 3 months or 5 half-lives (whichever is longer) of this IMP prior to screening - has a history of, or acknowledges, alcohol or other substance abuse in the 12 months before screening - is a female participant who is pregnant or breastfeeding, or plans to become pregnant during the study - has a known hypersensitivity to any components of the IMP - is of a vulnerable population (eg, people kept in detention or jail) - participant is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this study - Additional criteria apply; please contact the investigator for more information

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TEV-56286 		Orally administered capsules once daily
  • Drug: TEV-56286
    TEV-56286 capsules administered orally
    Other names:
    • emrusolmin, anle138b
Placebo Comparator
Placebo 		Orally administered capsules once daily
  • Drug: Placebo
    Matching placebo administered orally

Recruiting Locations

Teva Investigational Site 15554
La Jolla 5363943, California 5332921 92037

Teva Investigational Site 15545
Los Angeles 5368361, California 5332921 90095

Teva Investigational Site 15547
Washington D.C. 4140963, District of Columbia 4138106 20007

Teva Investigational Site 15544
Boca Raton 4148411, Florida 4155751 33486

Teva Investigational Site 15555
Tampa 4174757, Florida 4155751 33063

Teva Investigational Site 15550
Chicago 4887398, Illinois 4896861 60612-3852

Teva Investigational Site 15546
Kansas City 4273837, Kansas 4273857 66160

Teva Investigational Site 15736
Boston 4930956, Massachusetts 6254926 02115

Teva Investigational Site 15870
Farmington Hills 4992523, Michigan 5001836 48334

Teva Investigational Site 15552
Rochester 5043473, Minnesota 5037779 55905

Teva Investigational Site 15549
New York 5128581, New York 5128638 10016

Teva Investigational Site 15551
New York 5128581, New York 5128638 10032-3726

Teva Investigational Site 15553
Durham 4464368, North Carolina 4482348 27705-4410

Teva Investigational Site 15735
Hershey 5193342, Pennsylvania 6254927 17033

Teva Investigational Site 15548
Pittsburgh 5206379, Pennsylvania 6254927 15213

Teva Investigational Site 15869
Georgetown 4693342, Texas 4736286 78628

Teva Investigational Site 15873
Alexandria 4744091, Virginia 6254928 22310

Teva Investigational Site 15543
Spokane 5811696, Washington 5815135 99202

More Details

NCT ID
NCT06568237
Status
Recruiting
Sponsor
Teva Branded Pharmaceutical Products R&D LLC

Study Contact

Teva U.S. Medical Information
1-888-483-8279
USMedInfo@tevapharm.com

Detailed Description

We plan to open locations in the following countries: US, Israel, Italy, Spain, Germany, France, and Japan

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center